Effect of TTNS and PNS on Neurogenic Overactive Bladder Symptoms in Female Patients With Multiple Sclerosis.
- Conditions
- Multiple SclerosisOveractive Bladder Syndrome
- Interventions
- Device: TTNS (Transcutaneous tibial nerve stimulation)Device: PNS (Parasacral nerve stimulation)Device: Sham stimulationBehavioral: Behavioral treatment
- Registration Number
- NCT06143397
- Lead Sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Brief Summary
This study aims to evaluate the use of transcutaneous tibial nerve stimulation (TTNS) and parasacral nerve stimulation (PSS) methods in the treatment of overactive bladder (OAB) symptoms in patients with Multiple Sclerosis (MS), including urination frequency, urgency, urinary incontinence, post-void residue, maximum micturition rate. To investigate the effect on parameters such as voiding volume and quality of life and to compare the final results between groups.
- Detailed Description
Participants will be divided into 3 groups: TTNS, PNS, and placebo groups, and all participants will be given behavioral treatment. Tibial nerve stimulation will be given to the TTNS group, sacral nerve stimulation will be given to the PNS group, and sham current will be given to the placebo group. Stimulation treatments will be applied 2 days a week for 30 minutes each for 6 weeks. Participants will be evaluated before and after treatment. The parameters of urination frequency, urgency, and urinary incontinence will be evaluated with a 3-day voiding diary (BD), maximum flow rate (Qmax), time to reach maximum flow (TQmax), average flow rate, flow time (Tw), voiding time and voiding volume (VV) values will be evaluated by uroflowmetry, post-voiding residual (PVR) volume will be evaluated by ultrasound, and quality of life will be evaluated by King's Quality of Life Questionnaire (KHQ); Expanded Disability Status Scale (EDSS), Overactive bladder form (OAB-v8), Incontinence Severity Index (ISI), Neurogenic Bladder Symptom Score (NBSS) will be recorded.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 42
- Having symptoms related to overactive bladder (OAB-v8 score ⩾8),
- Over 18 years of age
- No relapse for at least 1 month
- All types of MS, including those with relapses
- Female MS patients with an Expanded Disability Status Scale (EDSS) score below 7.0
- Agreeing to participate in the research
- Patients with urinary tract infections
- Patients diagnosed with diabetes mellitus
- Patients using diuretic drugs or patients with a clean intermittent catheter
- Patients with a history of different urological diseases
- Patients with heart or brain pacemaker users, those with epilepsy, and patients with language and cognitive limitations
- Patients who are pregnant or in the postpartum period
- Lack of activity performance for 2 weeks (regardless of which group)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TTNS (Transcutaneous tibial nerve stimulation) TTNS (Transcutaneous tibial nerve stimulation) - PNS (Parasacral nerve stimulation) PNS (Parasacral nerve stimulation) - Sham stimulation Sham stimulation - TTNS (Transcutaneous tibial nerve stimulation) Behavioral treatment - PNS (Parasacral nerve stimulation) Behavioral treatment - Sham stimulation Behavioral treatment -
- Primary Outcome Measures
Name Time Method Uroflowmetry After the 6-week intervention It provides a valuable non-invasive assessment of voiding functions. It is the measurement of urine flow rate in ml/sec with the help of a flow meter. Since it is non-invasive among urodynamic tests, it can be used for screening purposes. Pattern and rate of flow depend on detrusor function and bladder outlet resistance.
Post voiding residue (PVR) After the 6-week intervention PVR will be measured using a 5-13-MHz convex ultrasound probe.
- Secondary Outcome Measures
Name Time Method Overactive bladder form (OAB-v8) After the 6-week intervention OAB-v8 is an eight-item screening test for overactive bladder (OAB) symptoms and has been validated in Turkish. The total score is between 0 and 40. Higher scores indicate OAB symptom burden and severity.
Neurogenic Bladder Symptom Score (NBSS) After the 6-week intervention The Neurogenic Bladder Symptom Score (NBSS) is a discriminatory tool developed for use in patients with spinal cord injuries, multiple sclerosis, and spina bifida. There are a total of 22 questions covering incontinence, storage and voiding symptoms, as well as urinary complications associated with neurogenic bladder dysfunction.
King's Quality of Life Questionnaire (KHQ) After the 6-week intervention One of the commonly used quality of life measures for urinary dysfunction is the King's Quality of Life Questionnaire. It is one of the most valid and widely used questionnaires that targets the quality of life in patients with urinary incontinence and precisely measures the impact of urinary incontinence symptoms on the quality of life.
Incontinence Severity Index (ISI) After the 6-week intervention Developed for use in epidemiological and clinical studies to identify women suffering from urinary incontinence, ISI, used in many different urinary incontinence studies, consists of two questions and the total score obtained by multiplying the frequency of urinary incontinence and the amount of urinary incontinence varies between 1 and 12.
Three-day bladder diary (BD) After the 6-week intervention BD contains the most critical parameters for measuring the frequency and severity of LUTS according to International Continence Society (ICS) recommendations and definitions. The 3-day bladder diary measures the frequency of urination, nocturia, urgency, and urge incontinence for 3 consecutive days. The average frequency of each symptom over three days will be considered the final result.
Trial Locations
- Locations (1)
Prof.Dr.Cemil Taşcıoğlu Şehir Hastanesi
🇹🇷Istanbul, Turkey